20 Participants Needed

Ultra Processed Food Diet for Obesity

(UPFEH Trial)

KJ
FM
Overseen ByFaris M Zuraikat, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how ultra-processed foods affect weight and energy use in the body. Participants will follow one of two diets: one where 80% of calories come from ultra-processed foods, and another with just 20%. Researchers will compare energy in stool samples to assess the impact of these diets on energy balance. Ideal candidates have a BMI between 30-40 kg/m², are weight stable, and do their own grocery shopping. Participants must also be willing to use a smartphone app for the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of using anti-obesity medications, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming a lot of ultra-processed foods links to weight gain and obesity. Individuals who eat more of these foods are more likely to develop health problems such as heart disease, diabetes, and high blood pressure. For those whose diet consists of 80% ultra-processed foods, the risk of obesity increases by 72% compared to those who avoid them.

Eating ultra-processed foods also raises the risk of issues like mental health disorders. Even when 20% of calories come from these foods, weight gain and similar health risks can occur. Although these foods offer convenience, the health risks are clear.12345

Why are researchers excited about this trial?

Researchers are excited about the Ultra Processed Food Diet for obesity because it explores how varying levels of ultra-processed foods in a diet impact weight management. Unlike traditional weight loss strategies that emphasize reducing processed food intake, this approach allows for a controlled consumption of these foods at two distinct levels: 20% and 80% of the diet. This trial could reveal important insights into how processed foods affect obesity, potentially challenging the current focus on cutting out these foods altogether and offering new dietary guidelines for managing weight.

What evidence suggests that this trial's diets could be effective for obesity?

This trial will compare two levels of ultra-processed food consumption. Studies have shown that consuming large amounts of ultra-processed foods is linked to weight gain and obesity. People who eat more of these foods generally have a higher Body Mass Index (BMI) and larger waistlines. Research found that for every 10% increase in these foods in a person's diet, the risk of obesity rises by 5%. Conversely, eating fewer ultra-processed foods is associated with less weight gain and better health. Reducing these foods might help manage weight and improve health. Participants in this trial will follow a diet consisting of either 80% or 20% ultra-processed foods to evaluate the impact on weight and health.12567

Who Is on the Research Team?

FM

Faris M Zuraikat, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI between 30-40 who have maintained their weight recently, can use an app throughout the study, do their own grocery shopping, and are generally healthy. It's not for pregnant individuals or those with a history of bariatric surgery or anti-obesity medication use.

Inclusion Criteria

My BMI is between 30 and 40.
Weight stable
Otherwise healthy
See 2 more

Exclusion Criteria

I have taken medication for weight loss before.
Pregnancy
I have had or am planning to have weight loss surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Testing

Participants undergo baseline testing including blood draw, metabolic test, and body composition test

1 week
1 visit (in-person)

Diet Phase 1

Participants follow a diet with either 80% or 20% ultra processed food for two weeks

2 weeks
1 visit (in-person) for dietitian meeting

Washout Period

Participants return to their usual diet and do not participate in research activities

2 weeks

Diet Phase 2

Participants switch to the alternate diet (80% or 20% ultra processed food) for two weeks

2 weeks
1 visit (in-person) for follow-up testing

Follow-up

Participants are monitored for changes in microbial taxa and fecal energy loss

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Ultra Processed Food Diet (20%)
  • Ultra Processed Food Diet (80%)
Trial Overview The study compares two diets: one where 80% of calories come from ultra processed foods and another where only 20% do. The focus is on how these diets affect the body's energy storage by analyzing calorie content in stool samples.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 80% Ultra processedExperimental Treatment2 Interventions
Group II: 20% Ultra processedExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

UNC Gillings School of Global Public Health

Collaborator

Trials
2
Recruited
800+

Published Research Related to This Trial

This systematic review and meta-analysis of 12 observational studies found that higher consumption of ultra-processed foods (UPF) is significantly associated with an increased risk of obesity (odds ratio of 1.55) and overweight (odds ratio of 1.36) in the general population.
Every 10% increase in UPF consumption in daily calorie intake correlates with a 7% higher risk of overweight, a 6% higher risk of obesity, and a 5% higher risk of abdominal obesity, indicating a clear link between UPF intake and excess weight.
Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis.Moradi, S., Entezari, MH., Mohammadi, H., et al.[2022]
In a study of 1082 older adults in Spain, higher consumption of ultra-processed foods (UPFs) was linked to a greater risk of developing dyslipidemia, specifically hypertriglyceridemia and low HDL cholesterol, over a follow-up period of 5 to 7 years.
Participants in the highest tertile of UPF consumption had more than double the odds of developing hypertriglyceridemia and low HDL cholesterol compared to those in the lowest tertile, suggesting that UPF intake may contribute to cardiovascular disease risk through these lipid abnormalities.
High Consumption of Ultra-Processed Food is Associated with Incident Dyslipidemia: A Prospective Study of Older Adults.Donat-Vargas, C., Sandoval-Insausti, H., Rey-García, J., et al.[2023]
In a study of 20 weight-stable adults over 4 weeks, participants consumed significantly more calories (508 kcal/day) while on an ultra-processed diet compared to an unprocessed diet, leading to weight gain.
The increased energy intake from ultra-processed foods was primarily due to higher carbohydrate and fat consumption, suggesting that reducing ultra-processed food intake could be a key strategy for preventing and treating obesity.
Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake.Hall, KD., Ayuketah, A., Brychta, R., et al.[2021]

Citations

Ultra-processed Food and Obesity: What Is the Evidence? - PMCObservational studies show positive associations between ultra-processed food intake and weight gain/obesity, with greater consumption being a ...
Ultra-processed food exposure and adverse health outcomesGreater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...
The impact of ultra-processed foods on pediatric healthHigher consumption is linked to pediatric obesity, cardiometabolic risks such as insulin resistance and metabolic dysfunction-associated steatotic liver disease ...
Ultraprocessed Food Consumption and Obesity ...In adults, UPF consumption is associated with increased obesity risk, but findings among children are inconsistent.
Ultra-processed food intake and its association with obesity ...Results: UPF consumption was associated with a 30.2% higher BMI, a 23% increase in mean waist circumference, and higher odds of having BMI > 25 kg/m2 and ...
Ultraprocessed or minimally processed diets following ...Higher UPF intakes are associated with increased risks of obesity, cardiometabolic disease, and all-cause mortality. As a result, countries ...
Ultra-Processed Foods and Human Health: A Systematic ...These findings show that UPF consumption is associated with higher risk of diabetes, hypertension, dyslipidemia, and obesity.
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